Regulatory, Clinical, and Biopharmaceutical Development

  • Hiten J. Gutka
  • Harry Yang
  • Shefali Kakar

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 34)

Table of contents

  1. Front Matter
    Pages i-xxiii
  2. Business, Health Economics and Intellectual Property Landscape for Biosimilars

  3. Regulatory Aspects of Development and Approval for Biosimilars

    1. Front Matter
      Pages 105-105
    2. Pekka Kurki, Niklas Ekman
      Pages 145-169
  4. Biopharmaceutical Development and Manufacturing of Biosimilars (Chemistry and Manufacturing Controls (CMC), Quality by Design (QbD), Quality Target Product Profile (QTPP))

    1. Front Matter
      Pages 171-171
    2. Christina Vessely, Christopher Bussineau
      Pages 187-219
    3. Satish K. Singh, Susanne Jörg, Hanns-Christian Mahler
      Pages 221-258
  5. Analytical Similarity Considerations for Biosimilars (Protein characterization, Biophysical Tools, Biological Assays, Statistical Methods)

    1. Front Matter
      Pages 259-259
    2. Kristof Vandekerckhove, Russell Reeve
      Pages 261-303
    3. Jared A. Young, John P. Gabrielson
      Pages 321-337
    4. Xu-Rong Jiang, Anthony Mire-Sluis
      Pages 393-430
    5. Harry Yang, Richard K. Burdick, Aili Cheng, Richard O. Montes
      Pages 431-468
  6. Clinical Aspects of Biosimilar Development (Clinical Trials, Immunogenicity, Extrapolation and Interchangeability)

    1. Front Matter
      Pages 469-469
    2. Harry Yang, Dongyue Fu, Lorin Roskos
      Pages 543-570
    3. Peijuan Zhu, Andrej Skerjanec
      Pages 571-599
    4. Hillel P. Cohen, William C. Lamanna, Martin Schiestl
      Pages 601-628
  7. Biosimilars: Global Development and Clinical Experience

    1. Front Matter
      Pages 629-629
    2. Thomas Felix, Binakumari Patel, Brian D. Bradbury, Gustavo Grampp
      Pages 631-652
    3. Anurag S. Rathore, Srishti Joshi, Ankita Bhargava, Neh Nupur
      Pages 653-674
  8. Back Matter
    Pages 693-709

About this book


This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. 

For the ease of readers, the book comprises of six sections as follows:

Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars

Section II: Regulatory Aspects of Development and Approval for Biosimilars

Section III: Biopharmaceutical Development and Manufacturing of Biosimilars

Section IV: Analytical Similarity Considerations for Biosimilars

Section V: Clinical aspects of Biosimilar Development

Section VI: Biosimilars- Global Development and Clinical Experience

Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.


therapeutics quality by design biologics preclinical safety chemistry and manufacturing controls (CMC)

Editors and affiliations

  • Hiten J. Gutka
    • 1
  • Harry Yang
    • 2
  • Shefali Kakar
    • 3
  1. 1.Oncobiologics Inc.CranburyUSA
  2. 2.Statistical Sciences, MedImmune LLCGaithersburgUSA
  3. 3.Novartis (United States)East HanoverUSA

Bibliographic information

  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2018
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-319-99679-0
  • Online ISBN 978-3-319-99680-6
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site
Industry Sectors
Health & Hospitals
Consumer Packaged Goods